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Propoxyphene

Published: July 26, 2026Updated: August 20, 2026

Propoxyphene is a synthetic opioid analgesic that was used for the treatment of mild to moderate pain. It was available both as a single-agent formulation and in combination with acetaminophen or aspirin.

Quick summary

A weak opioid pain medication that was withdrawn from the US market in 2010 due to safety concerns.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 20, 2026Editorial policy

Key facts at a glance

ATC
N02AC04
RxNorm
8785
Generic
Propoxyphene
Class
atc-n02
Brands
—
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet, capsule
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause serious toxicity
Chronic overdose: cumulative toxicity with repeated dosing above therapeutic levels
Immediate actions
airway management, activated charcoal, supportive care
Antidote
Naloxone(effective for reversing respiratory depression)
Poison Control: 1-800-222-1222

Special Populations

10 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring and growth assessment

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid

Key Recommendations

avoid use near term due to risk of neonatal withdrawal and respiratory depression

Monitor

neonatal assessment for withdrawal symptoms

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
contraindicated
FDA Category
C
Dose Adjustment

discontinue breastfeeding or avoid drug

Key Recommendations

propoxyphene passes into breast milk; do not use while breastfeeding

Monitor

monitor infant for excessive sleepiness or breathing difficulties

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

reduce dose by 25-50%

Key Recommendations

use with extreme caution in patients over 65 years; start at lowest effective dose

Monitor

monitor for sedation, dizziness, constipation, and respiratory depression

Use with caution and monitor for adverse effects.

✗

pediatric_age

children adolescents
contraindicated
FDA Category
C
Dose Adjustment

not recommended

Key Recommendations

not recommended for use in children under 18 years due to safety concerns

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

mild renal impairment
caution
FDA Category
N
Dose Adjustment

reduce dose by 25%

Key Recommendations

use with caution; monitor renal function

Monitor

monitor renal function and drug accumulation

Use with caution and monitor for adverse effects.

✗

renal_impairment

severe renal impairment
unsafe
FDA Category
N
Dose Adjustment

avoid or significantly reduce dose

Key Recommendations

use with extreme caution or avoid in patients with severe renal impairment

Monitor

frequent monitoring of renal function and drug levels

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

hepatic_impairment

mild hepatic impairment
caution
FDA Category
N
Dose Adjustment

reduce dose by 25%

Key Recommendations

use with caution; monitor liver function

Monitor

monitor hepatic function and drug metabolism

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe hepatic impairment
unsafe
FDA Category
N
Dose Adjustment

avoid

Key Recommendations

avoid in severe hepatic impairment due to significantly altered metabolism

Monitor

frequent hepatic function monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

Market status

Value:Withdrawn from US market

Propoxyphene was withdrawn from the US market in 2010 due to cardiac toxicity concerns

drug_classWHO
2023

Drug class

Value:Synthetic opioid analgesic

Opioid analgesic classification

usageMedical guidelines
2023

Common uses

Value:Mild to moderate pain relief

Therapeutic indications for propoxyphene

safetyFDA
2023

Safety concern

Value:Cardiac toxicity

Reason for market withdrawal

Propoxyphene was previously indicated for the relief of mild to moderate pain, including postoperative pain, dental pain, and musculoskeletal discomfort. It was commonly prescribed for conditions requiring around-the-clock pain management.

Propoxyphene binds to mu-opioid receptors in the central nervous system, altering the perception of pain and producing analgesic effects. As a weak opioid agonist, it has approximately one-half to two-thirds the potency of codeine.

Propoxyphene was withdrawn from the US market in 2010 due to FDA concerns about cardiac arrhythmias, including QT prolongation, and increased risk of overdose even at recommended doses. It has been replaced by safer alternatives for pain management. Patients currently seeking pain relief should consult healthcare providers about other appropriate analgesic options.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 20, 2026. · Read our editorial policy